To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | June 2008 |
| End Date: | November 2008 |
A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 80-mg Tablets Manufactured at the Totowa, NJ Facility to Oxycodone Tamper Resistant (OTR) 80-mg Tablets Manufactured at the Wilson, NC Facility
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80
mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured
at the Wilson, NC facility in the fasted state.
mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured
at the Wilson, NC facility in the fasted state.
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective
in the relief of moderate to severe malignant and non-malignant pain.
in the relief of moderate to severe malignant and non-malignant pain.
Inclusion Criteria:
- Males and females aged 18 to 50, inclusive.
- Body weight ranging from 50 to 100 kg and a BMI ≥18 and ≤34 (kg/m2).
- Healthy and free of significant abnormal findings as determined by medical history,
physical examination, vital signs, and ECG.
- Females of child-bearing potential must be using an adequate and reliable method of
contraception.
Exclusion Criteria:
- Females who are pregnant or lactating.
- Any history of or current drug or alcohol abuse for 5 years.
- History of or any current conditions that might interfere with drug absorption,
distribution, metabolism or excretion.
- Use of an opioid-containing medication in the past 30 days.
- History of known sensitivity to oxycodone, naltrexone, or related compounds.
- Any history of frequent nausea or emesis regardless of etiology.
- Any history of seizures or head trauma with current sequelae.
- Participation in a clinical drug study during the 30 days preceding the initial dose
in this study.
- Any significant illness during the 30 days preceding the initial dose in this study.
- Use of any medication including thyroid hormone replacement therapy (hormonal
contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7
days preceding the initial dose.
- Refusal to abstain from food for 4 hours following administration of the study drugs
and to abstain from caffeine or xanthine entirely during each confinement.
- Consumption of alcoholic beverages within forty-eight (48) hours of initial study
drug administration (Day 1) or anytime following initial study drug administration.
- History of smoking or use of nicotine products within 45 days of study drug
administration or a positive urine cotinine test.
- Blood or blood products donated within 30 days prior to administration of the study
drugs or anytime during the study, except as required by this protocol.
- Positive results for urine drug screen or alcohol screen at Check-in of each period,
and HBsAg, HBsAb (unless immunized), anti-HCV.
- Positive Naloxone HCl challenge test.
- Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
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